NEWS

A unique safety data sheet for cell and gene therapies

3 October 2023
Advanced Therapy Medicinal Products
Rachel Hodges
Senior Global Change Facilitator

A safety data sheet (SDS) is an established hazard communication tool in the chemical industry, for which no comparable or mandated document exists in the biotherapeutics sector yet is increasingly requested by the supply chain. As the cell and gene therapy (CGT) field expands, industry leaders and members of BioPhorum have identified a growing need to address this gap in communication around the unique occupational health and safety risks posed by CGT materials and products.

This new paper, An Industry Proposal for a Cell and Gene Therapy Safety Data Sheet, provides you with a best practice for communicating workplace hazards, assessing the unique risks posed by these biological materials, and can help in creating exposure control plans specific to the workplace hazards.

Published in the Journal of Applied Biosafety, it contains 16 narrative sections ranging from hazard identification and composition/information on ingredients, to disposal considerations and transport information. If you are an SDS author, these provide useful context and background details, followed by a table that includes example information. There is also a downloadable template that you can use to communicate workplace hazards and assess the risks posed by CGT materials, available from the BioPhorum website.

The paper includes information on conducting a workplace risk assessment and communicating the unique hazards posed by potential exposures to CGT materials. It is based on assumptions of a maximum Biosafety Level 2.

Example use cases include:

  • Transport of CGT bioactive product and intermediates across sites during R&D, manufacturing, or testing processes
  • Technical transfer of CGT bioactive products and intermediates between client and contract manufacturing organization
  • Operations in the R&D labs, manufacturing plants, packaging, and clinical and healthcare settings.

It is aimed at those handling and producing these materials, as well as collaborators, contractors, or operations sites receiving and handling the CGT material. However, it may also be helpful as a reference for other biotherapeutic modalities such as protein therapies, mRNA, and plasmids.

With no established tool in the field, this guide contains industry best practices with aspirations of becoming a standard communication for workplace hazards unique to CGT biological materials and products. For more information, contact Rachel Hodges, Senior Global Change Facilitator, at rachel.hodges@biopho

Cells Under Microscope
NEWS
Control of empty, full and partially filled capsids – BioPhorum establishing an industry position on this critical quality attribute
Scenic Bridge
NEWS
Bridging the worlds of IT and CGT through analogies
Orchestra Conductor
NEWS
Orchestrating the supply of different cell and gene therapies
Scientists Gene Therapy
NEWS
Guidance on minimizing the impact of stability studies on gene therapy batch yield
Cells On Purple Background
NEWS
Best practices for demonstrating comparability for clinical cell-based therapies

Advanced Therapy Medicinal Products

Advanced Therapy Medicinal Products support the quest for better and faster development of cell, gene and RNA therapies​ through connecting therapy developers, contract manufacturing, and testing organizations to gain an understanding and respond to the challenges faced by the advanced therapeutics industry.

Development Group

Development Group accelerates and improves the development process of biopharmaceutical medicines for the benefit of the patient. Replacing isolation with collaboration by providing a “safe” space where subject matter experts can work on sharing solutions and best practice on emerging industry trends, implementation of new technologies and common issues whilst ensuring their intellectual property and confidentiality is protected.

Drug Substance

Drug Substance advances excellence in drug substance manufacturing and testing, acting as an industry voice to accelerate technology adoption, implement post-approval change more rapidly and increase confidence in maintaining compliance.

Fill Finish

Fill Finish accelerates development and acceptance of sustainable world-class filling and packaging operations for drug product which meets the future needs of patients. Through innovative solutions resulting from the sharing of expertise, we can overcome common performance challenges and deliver on quality and regulatory compliance.

Information Technology

Information Technology accelerates digital maturity across the ​global pharmaceutical manufacturing industry.

Quality

BioPhorum Quality provides a dedicated, safe space for quality professionals from biomanufacturers and contract organizations to coalesce and enhance effective collaboration to address shared industry challenges.

Regulatory-CMC

Regulatory CMC brings leaders together who have a common goal – to improve access to medicines through innovation in the Regulatory ecosystem. It provides a dedicated space for strategic leadership and a coordinated industry voice, to move from divergence to convergence.

Supply Chain to Patient

Supply Chain to Patient transforms the performance of global pharmaceutical clinical and commercial outbound supply chains through industry collaboration by creating transparent patient-centric, resilient and agile E2E supply chains, that consistently deliver high-quality medicines ensuring an uninterrupted supply to patients.

Supply Partner

Supply Partner is a trusted advisory group and collaboration that is the engine for driving change across the global industry for all things relevant to the inbound supply chain. Addressing the challenges of complexity, resilience, cost, sustainability, and innovation.

Sustainability

Sustainability enables the industry’s transition to a low carbon, circular future – supporting members to improve patient health while respecting the planet. We activate multi-disciplinary teams drawn from our network to deliver environmental sustainability improvements across the value chain.

Technology Strategy

Technology Strategy acts as one voice of the industry to define strategy, accelerate technology transformation and support technology translation and adoption. With a purpose of enabling the future state of flexible, resilient, sustainable end-to-end biomanufacturing.

DOWNLOAD
An industry perspective on understanding AAV capsid content variants
Needle On Yellow Background
EXTERNAL-RESOURCE
An intercompany perspective on practical experiences of predicting, optimizing and analyzing high concentration biologic therapeutic formulations
DOWNLOAD
The Drug Substance 2.0 Strategic Value Framework
Coloured dots on teal, next to vial
DOWNLOAD
BioPhorum’s holistic approach to container closure integrity
Magnifying glass over a tablet all coloured blue
DOWNLOAD
Digital Plant Maturity Model 3.0
NEWS
Inaugural BioPhorum Quality face to face – get involved
PODCAST
The next step in building regulatory as a capability to enable strategic innovation across the BioPhorum community
PODCAST
Delivering a Cell and Gene Therapy Outbound Supply Chain Pathway for the Industry
DNA and Earth on blue background
DOWNLOAD
A vision for the biopharmaceutical industry’s inbound supply chain
NEWS
A major milestone – a harmonized approach to product carbon footprint data
Technology Roadmap V 2.0
DOWNLOAD
BioPhorum Technology Roadmapping roadmap vision 2.0

Publications

Documents including best practices, vision statements and peer reviewed papers to help you take value back to your business.

Webinars

Discussing all aspects of the biopharmaceutical industry, from digitization and knowledge management to raw materials, supply chain, sustainability and more. Learn from the perspectives of those at the forefront of the industry.

Podcasts

BioPhorum Connect is our podcast series that keeps you up to date with the latest news and trends in the biopharmaceutical industry. From experienced professionals to thought leaders, these podcasts bring you the insights and perspectives of experts from around the world.

Tools

A variety of resources including design tools and user requirement specifications to help you improve and streamline your business processes.

Benchmarks and Surveys

Research conducted among the BioPhorum membership providing evidence to support change and identify best practice.

Browse all

Access a variety of free tools and papers and other resources designed to provide you with up-to-date information and insights to help you make informed decisions and maximize your success. Access our resources today and start making improving and streamlining your business processes.

WEBINAR
Bioreactivity testing in single-use system biomanufacturing
WEBINAR
Bioreactivity testing in single-use system biomanufacturing
WEBINAR
Bioreactivity testing in single-use system biomanufacturing
Magnifying glass over a tablet all coloured blue
DOWNLOAD
Digital Plant Maturity Model 3.0
WEBINAR
Bioreactivity testing in single-use system biomanufacturing